MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-JUG-CELECT

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Pain (1994); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer reference # (b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "shortness of breath, chest pain". Cook will reopen its investigation if further information is received. Unknown if the reported shortness of breath, chest pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

Manufacturer Narrative

Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Additional information: investigation: investigation is reopened due to additional information provided. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "shortness of breath, chest pain". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported shortness of breath, chest pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time. No other complaints on lot. Product is manufactured and inspected according to specifications. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

Event Description

No additional information or changes at this time.

Manufacturer Narrative

(b)(4). Catalog #: unknown but referred to as a cook celect filter. Expiration date: unknown as lot # is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. Mfr date unknown as lot # is unknown. Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010 at (b)(6) hospital. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number (b)(4) william cook europe aps (manufacturer) is submitting this report on behalf of (b)(4). (b)(4). (b)(6). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 4/24/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the jugular vein due to femur fracture. Plaintiff is alleging shortness of breath and chest pain.

• Brand Name: NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 5764364
• MDR Text Key: 208751522
• Report Number: 3002808486-2016-00651
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/07/2016
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E3043306
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 06/22/2016
• Event Location: No Information
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/01/2016 Patient Sequence Number: 1